# K222245: ACR Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Biomaterials Korea, Inc.
- Decided: Aug 21, 2023 after 391 days
- Product code: OAT (Implant, Endosseous, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K063495 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063495: C Type, CT Type, and Special Type Orthodontic Anchor Screws, Biomaterials Korea, Inc. (2007) Summary page 4.

## Indications for use
The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth for use in patients 12 years of age and older. It is used temporarily and is removed after orthodontic treatment is complete. The screws are intended for single use only.

Source page: https://510kreport.com/device/K222245
Methodology: https://510kreport.com/methodology